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Sodium Glucose Cotransporter-2 Inhibitor Treatment and the Risk of Diabetic Ketoacidosis in Denmark: A Retrospective Cohort Study of Five Years of Use

[ Vol. 16 , Issue. 1 ]

Author(s):

Henrik V.B. Laursen*, Johan B. Røikjer, Jakob Dal and Morten Hasselstrøm Jensen   Pages 73 - 81 ( 9 )

Abstract:


Background: Sodium-glucose cotransporter 2 inhibitors (SGLT2i) have been associated with increased risk of diabetic ketoacidosis (DKA) in both people with type 1 and type 2 diabetes mellitus. Few studies using data from high-quality registries exist that attempt to determine the real- world impact of the increasing use of this drug.

Objective: The aim of this study was to investigate the incidence and risk of DKA in connection with SGLT2i treatment in Denmark between 2013-2017.

Method: A nationwide retrospective cohort of people with type 2 diabetes mellitus using SGLT2i or glucagon-like peptide-1 receptor agonists (GLP1-RA) was established and analysed using both Cox-proportional hazard regression and Kaplan-Meier survival analysis.

Result: The 37,058 individuals included in the cohort, were made up of SGLT2i (10,923), GLP1- RA (18,849), SGLT2i+insulin (2,069), and GLP1-RA+insulin (10,178) users. The incidence rate (IR) of DKA was 0.84 (95% CI 0.49-1.44) and 0.53 (95% CI 0.36-0.77) for the SGLT2i and GLP1-RA groups, respectively. There was no statistically significant increase in the risk for DKA with SGLT2i use (HR 1.02, 95% CI, 0.44-2.36). However, for the SGLT2i+insulin and GLP1- RA+insulin groups, IRs were 3.47 (95% CI 1.92-6.27) and 0.97 (95% CI 0.68-1.37) respectively, and the risk was statistically significantly higher (HR 5.42, 95% CI 2.16-13.56).

Conclusion: We observed no significant increase in the risk of DKA for SGLT2i users compared to GLP1-RA. However, a significantly higher IR of DKA was observed with concomitant insulin use, and the risk of DKA was considerably higher for the SGLT2 group using insulin.

Keywords:

Sodium-glucose cotransporter 2 inhibitors, retrospective cohort, diabetic ketoacidosis, hyperglycaemia, insulin, Kaplan- Meier.

Affiliation:

Steno Diabetes Center North Denmark, Aalborg University Hospital, Mølleparkvej 4, 9000 Aalborg, Steno Diabetes Center North Denmark, Aalborg University Hospital, Mølleparkvej 4, 9000 Aalborg, Steno Diabetes Center North Denmark, Aalborg University Hospital, Mølleparkvej 4, 9000 Aalborg, Steno Diabetes Center North Denmark, Aalborg University Hospital, Mølleparkvej 4, 9000 Aalborg



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